The Risk – Benefit Analysis: When Is the Risk of Injury Worth Taking the Drug?

By Robert Schwartz

Lawsuits filed against drug companies seek compensation for serious injuries caused by their drugs. The vast majority of the drugs that are the subject of lawsuits only treat symptoms of diseases and disorders; they are not drugs that cure diseases and disorders. There is a huge difference between the two in terms of the acceptable risks, and there are far fewer lawsuits regarding drugs that are necessary or vital to sustaining life. The risks associated with drugs that only treat symptoms are heavily scrutinized because some relief from symptoms may not be worth the drug’s risk of serious injury.

To make this determination, every patient has to have all of the information about all of a drug’s known risks before taking it. This information comes from the drug’s warnings, and it is supposed to contain all of the risks that the drug company is aware of. The drug companies have a duty to update those warnings as new risks are found. For drugs prescribed only to treat symptoms, these risks must be weighed against the nuisance of the symptoms to be treated. For drugs that cure diseases and disorders, while the warnings need to be accurate and complete, the patient may decide that the known potential risks are equal to or even greater than the potential of the drug’s benefits, and they may decide to take the drug anyway. The prescribing physician will help the patient with understanding this information, but make no mistake — it is always the patient’s decision.

One recent example of such a drug that cures diseases is Sprycel (dasatinib), a fairly new leukemia drug that received its Food and Drug Administration (FDA) approval in June 2006. Sprycel is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). It works by blocking the action of an abnormal protein that signals cancer cells to multiply, thereby placing the cancer in remission. Sprycel does have serious risks that a patient could consider outweigh its benefits.

One such serious risk was brought to the public’s attention on October 11, 2011. On that date, an FDA Drug Safety Communication was issued warning the public that Sprycel may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension, or PAH). PAH causes the heart to work harder to pump the blood into the lungs and, over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. PAH is a very serious and potentially life-threatening condition. At a minimum, it is a life-altering condition that can negatively affect the patient’s quality of life.

However, Sprycel’s benefit is its potentially effective treatment of two very serious types of leukemia: chronic myelogenous leukemia (CML) and acute myeloid leukemia (AML). Untreated, CML and AML will cause the patient’s death. Treated with Sprycel, the patient accepts the PAH risks as a tradeoff for the potential remission of the bone cancer. Ultimately, the risk in taking or not taking Sprycel may be the same: death. To the patient, the potential benefit may far outweigh the potential risk. Again, to make this decision, the patient has to have the same knowledge as the drug company has of the risks of serious side effects.

So, while the issue in drug litigation is always about what the drug company knew, when did it know it and if it put what it knew in the drug’s warnings, that may be overshadowed by the patient’s decision to accept all risks for a potential cure of a deadly disease or condition. Patients are entitled to accurate and complete information about a drug’s risks of injury so they can decide if the risk of injury is worth taking the drug.

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